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Trial registered on ANZCTR
Registration number
ACTRN12611001108909
Ethics application status
Approved
Date submitted
20/10/2011
Date registered
25/10/2011
Date last updated
3/01/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of mobilization of the neuraxis in patients with temporomandibular dysfunction.
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Scientific title
Effect of central nervous system mobilization versus cervical mobilization on degree of mouth opening in patients with temporomandibular dysfunction
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Secondary ID [1]
273243
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Nil
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Universal Trial Number (UTN)
U1111-1125-3325
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorders
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Condition category
Condition code
Physical Medicine / Rehabilitation
279187
279187
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0
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Physiotherapy
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Musculoskeletal
279195
279195
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
-Mobilization neurodynamic of the central nervous system by collapse or slump position. Playing with cervical flexion and knee extension and ankle dorsiflexion.
Treatment administered by a physiotherapist.
-1 x 15 minute session per week;
-12 weeks
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Intervention code [1]
269577
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Rehabilitation
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Intervention code [2]
269585
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Treatment: Other
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Comparator / control treatment
One control group.
The Active group treatment is only passive motion cervical as it is possible that participants may benefit from this treatment
Treatment administered by a physiotherapist.
1 x 15 minute session per week;
-12 weeks
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Control group
Active
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Outcomes
Primary outcome [1]
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Improvement of mouth opening
Is evaluated with digital calipers.
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Assessment method [1]
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Timepoint [1]
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3 month
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Secondary outcome [1]
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Improved pain
Is evaluated with "pressure algometer"
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [2]
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Improved cervical mobility
Is evaluated with goniometry
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Assessment method [2]
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Timepoint [2]
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3 months
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Eligibility
Key inclusion criteria
Sign an "informed consent" to participate in the study. This document briefly explains the objectives of the study, guaranteeing confidentiality of the data according to the law 15/1999 of Protection of Personal Data.
- Submit a decrease in joint range of the temporomandibular joint in the vertical opening less than 40 mm at the discretion of Maglione.
- Have symptoms of cracking and / or noise in the temporomandibular joint.
- Pain in the facial and masticatory muscles
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Minimum age
20
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Having a chronic rheumatic disease (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and so on.
- Having had a fracture and / or trauma to the jaw, mandibular condyle, cervical spine, cranial vault or skull base.
- Being pregnant.
- Post-surgical state any surgery three months prior to study participation.
- Submit neurodegenerative diseases.
- Have taken muscle relaxants or anti-inflammatory medication in the last 24 hours.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/01/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3915
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Spain
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State/province [1]
3915
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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JOSE ANTONIO PEREZ MOSCOSO
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Address [1]
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CALLE ATAHONA , NUMBER 4
MEDINA SIDONIA ( CADIZ) CP: 11170
SPAIN
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Country [1]
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Spain
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Primary sponsor type
Individual
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Name
ANGEL OLIVA PASCUAL-VACA
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Address
University of Sevilla
CALLE SAN FERNANDO 4
SEVILLA (SEVILLA) CP: 41004
SPAIN
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Country
Spain
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Secondary sponsor category [1]
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University
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Name [1]
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UNIVERSIDAD DE SEVILLA
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Address [1]
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CALLE SAN FERNANDO 4
SEVILLA (SEVILLA) CP: 41004
SPAIN
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Country [1]
269035
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Spain
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
The overall objective of this study is to improve mouth opening in temporomandibular joint mobilization of the neuraxis, and to analyze the additional effects in reducing pain at the level of the masseter, cervical muscles and trigeminal branches and improving the cervical mobility in all three planes of space.
The aim is to check with trigeminal nerve enhancement and nerve trunk there is an increased mobility of the temporomandibular joint and a consequent decrease in pain sensitivity. Using the collapse or slump position for treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
33287
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Contact person for public queries
Name
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JOSE ANTONIO PEREZ MOSCOSO
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Address
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CALLE ATAHONA NUMBER 4
MEDINA SIDONIA (CADIZ) CP: 11170
SPAIN
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Country
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Spain
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Phone
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+34 605472359
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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ANGEL OLIVA PASCUAL VACA
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Address
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UNIVERSITY OF SEVILLA
CALLE SAN FERNANDO NUMBER 4
SEVILLA CP: 41004
SPAIN
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Country
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Spain
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Phone
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+34 630254399
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Fax
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Email
7462
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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